Predictive Factors of Response to Somatostatin Analogues in Acromegalic Patients With Persistent Disease Following Surgery

NCT ID: NCT00500227

Last Updated: 2019-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

Study Completion Date

2012-07-31

Brief Summary

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The objective of this study is to evaluate, in acromegalic patients with disease persistence after surgery who are treated with somatostatin analogues, the histopathological, clinical, morphological and biochemical factors which are predictive of hormonal control.

Detailed Description

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Conditions

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Acromegaly

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Acromegalic patients with persistent disease (growth hormone ≥ 1ng/ml following oral glucose tolerance test and/or insulin like growth factor 1 above the normal range for sex and age) 3 to 6 months after transsphenoidal or transfrontal surgery

Exclusion Criteria

* Patients not contributing enough material for a tumour histopathological study
* Patients who have received radiation therapy or will receive it during the observational study period
* Patients who are being treated, or in whom treatment is anticipated, with either a dopaminergic agonist or a growth hormone receptor antagonist
* Patients with a history of hypersensitivity to somatostatin analogues
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ipsen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

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Hospital "Juan Canalejo"

A Coruña, , Spain

Site Status

Hospital General Universitari d'Alacant

Alicante, , Spain

Site Status

Hospital de Cruces

Barakaldo, , Spain

Site Status

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status

Hospital General de la Vall d´Hebron

Barcelona, , Spain

Site Status

Hospital Clínic i Provincial de Barcelona

Barcelona, , Spain

Site Status

Hospital "Mútua de Terrassa"

Barcelona, , Spain

Site Status

Hospital Prínceps d'Espanya

Barcelona, , Spain

Site Status

Hospital Universitario de Getafe

Getafe, , Spain

Site Status

Complejo Hospitalario de León. Hospital Virgen Blanca.

León, , Spain

Site Status

Complejo Hospitalario Xeral-Calde de Lugo

Lugo, , Spain

Site Status

Hospital de La Princesa

Madrid, , Spain

Site Status

Hospital "Ramón y Cajal"

Madrid, , Spain

Site Status

Hospital Universitario Puerta de Hierro

Madrid, , Spain

Site Status

Fundación Jiménez Díaz

Madrid, , Spain

Site Status

Hospital Clínico de Madrid

Madrid, , Spain

Site Status

Hospital Universitario "12 de Octubre"

Madrid, , Spain

Site Status

Hospital Universitario "La Paz"

Madrid, , Spain

Site Status

Complexo Hospitalario de Orense

Ourense, , Spain

Site Status

Hospital "Son Dureta"

Palma de Mallorca, , Spain

Site Status

Hospital de Navarra

Pamplona, , Spain

Site Status

Hospital Nuestra Señora de la Candelaria

Santa Cruz de Tenerife, , Spain

Site Status

Hospital "Marqués de Valdecilla"

Santander, , Spain

Site Status

Hospital Clínico Universitario de Santiago

Santiago de Compostela, , Spain

Site Status

Hospital "Joan XXIII"

Tarragona, , Spain

Site Status

Hospital Clínico Universitario de Valencia

Valencia, , Spain

Site Status

Hospital Clínico de Valladolid

Valladolid, , Spain

Site Status

Complejo Hospitalario Xeral-Cies de Vigo

Vigo, , Spain

Site Status

Hospital "Miguel Servet"

Zaragoza, , Spain

Site Status

Hospital Clínico Universitario "Lozano Blesa"

Zaragoza, , Spain

Site Status

Countries

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Spain

Other Identifiers

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A-92-52030-728

Identifier Type: -

Identifier Source: org_study_id

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